FDA Authorizes Updated COVID-19 Vaccines for Emergency Use

The U.S. Food and Drug Administration (FDA) just authorized the 2023-2024 updated mRNA Moderna and Pfizer-BioNTech COVID-19 vaccines for emergency use.  These updated vaccines have been “formulated to more closely target currently circulating variants,” and “include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.”  Individuals’ eligibility for the updated COVID-19 vaccines is:  regardless of previous vaccination 5 years of age and older may receive 1 dose at least 2 months since previous dose; previously vaccinated 6 months through 4 years of age may receive 1 or 2 doses (depending on previously received vaccine); unvaccinated 6 months through 4 years of age may receive 3 doses of Pfizer-BioNTech or 2 doses of Moderna.  In mid-June, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) discussed recommendations for updated COVID-19 vaccines for use in 2023-2024.  Based on the VRBPAC’s recommendation, the FDA advised manufacturers updating their COVID-19 vaccines to develop them with a monovalent XBB.1.5 composition.  For additional information on the updated vaccines, see the 9/11/2023 FDA News Release.